Compounding device, system, kit, software, and method

ABSTRACT

An exemplary compounding system and method can include a transfer set that includes a manifold for assisting in transferring a plurality of ingredients from supply container(s) to a final container. The manifold can include a first channel in fluid communication with at least one primary ingredient, and a second channel in fluid communication with a plurality of secondary ingredients. The first channel and second channel can be in fluid isolation from each other such that the at least one primary ingredient does not mix with the plurality of secondary ingredients within the manifold. The transfer set can include a plurality of inlet lines in fluid communication with the manifold and two outlet lines configured for connection to two separate pumps and eventually being in fluid communication with the final container.

This application is a Divisional of and claims the priority benefitunder 35 U.S.C. § 120 of U.S. patent application Ser. No. 15/655,321filed Jul. 20, 2017 issuing as U.S. Pat. No. 11,541,222 on Jan. 3, 2023which in turn is a divisional application claiming priority under 35U.S.C. § 120 to U.S. patent application Ser. No. 14/700,779 filed Apr.30, 2015 now U.S. Pat. No. 9,802,171 which in turn claims priority toU.S. patent application Ser. No. 14/693,867 filed on Apr. 23, 2015 nowU.S. Pat. No. 11,357,966, each of which are hereby incorporated in theirentireties by reference.

BACKGROUND 1. Field

The presently disclosed subject matter relates generally to devices,systems, software, kits, and methods for preparing admixtures of variousfluids, such as pharmaceuticals, assays, nutritional fluids, chemicals,and other fluids, for administration to human, animal, plant,mechanical/electrical/chemical/nuclear systems, or other users. In oneexemplary embodiment, the disclosed subject matter can relate todevices, systems, software, kits and methods in which a plurality ofparenteral ingredients are mixed or compounded together for delivery toa patient or user via an infusion or intravenous bag (e.g., forintravenous, intra-arterial, subcutaneous, epidural, or othertransmission).

2. Description of the Related Art

Compounding involves the preparation of customized fluid ingredientsincluding medications, nutritional liquids, and/or pharmaceuticals, on apatient-by-patient basis. Compounded medications and solutions can bemade on an as needed basis whereby individual components are mixedtogether to form a unique solution having the strength and dosage neededby the patient. This method allows the compounding pharmacist to workwith the patient and/or the prescriber to customize a medication to meetthe patient's specific needs. Alternatively, compounding can involve theuse of a compounding device to produce compounds in an anticipatoryfashion, such as when a future or imminent demand for a particularcombination of medicaments or pharmaceuticals or other compoundcomponents is known. Further, compounding devices can be used to producepooled bags, for example, that include certain fluids that are neededfor either a number of patients or for the same patient for a number ofdays or a number of administrations. Thus, the pooled bag(s) can be usedby including further specific compounding components, if any, either fora specific patient or for a specific timing for the same patient.

Compounding devices typically use three types of measuring methods:gravimetric (e.g., additive gravimetric (weight final container) orsubtractive gravimetric (weight the source containers as the pumpdelivers)), volumetric, or a combination of gravimetric and volumetricwhere each type can be used to check the other type. Compounders can befurther broken down into three categories based on the minimum volumesthey can deliver and the number of components they can accommodate:macro, micro, or macro/micro. Compounders typically have a statedminimum measurable volume and accuracy range. When compounding, highervolumes usually have larger absolute deviations, but lower percentagedeviations. Operating software has been used to maximize theeffectiveness and efficiency of compounding devices.

Gravimetric devices generally use a peristaltic pump mechanism combinedwith a weight scale or load cell to measure volume delivered. The volumedelivered is calculated by dividing the weight delivered by the specificgravity of the ingredient. Gravimetric devices are not typicallyaffected by running the source containers empty and delivering air intothe final bag. These devices can be calibrated by using a referenceweight for each ingredient. For example, the device's load cell can becalibrated using a reference mass on the load cell, and individualamounts of fluid dispensed measured by the load cell can be correctedbased on the specific gravity of the fluid being dispensed.

Volumetric devices generally use both a peristaltic pump mechanism and a“stepper” motor to turn the pump mechanism in precisely measurableincrements. The device calculates the volume delivered by the precisionof the delivery mechanism, internal diameter of the pump tubing,viscosity of the solution, and the diameter and length of the distal andproximal tubing. Delivery from these devices can be affected by manyfactors including: variances in the pump tubing's material, length,elasticity, and diameter; temperature, which affects solution viscosityand tubing size; total volume pumped; ingredient head height; final bagheight; position (e.g., initial and final positions) of the pump rollersrelative to the pump platens; and empty source components. Thickness ofthe pump tubing can significantly affect delivery accuracy, and wear onthe pumps over time can also cause diminishing accuracy.

Monitoring and replacing source containers before they are empty canprevent the volumetric devices from delivering air in lieu of theingredient to the final container.

In some cases, due to injury, disease, or trauma, a patient may need toreceive all or some of his or her nutritional requirementsintravenously. In this situation, the patient will typically receive abasic solution containing a mixture of amino acids, dextrose, and fatemulsions, which can provide a major portion of the patient'snutritional needs. These mixtures are commonly referred to as parenteralmixtures (“PN”). Parenteral mixtures that do not include lipids arecommonly referred to as total parenteral nutritional mixtures (“TPN”),while parenteral mixtures containing lipids are referred to as totalnutritional admixtures (“TNA”). Often, to maintain a patient for anextended period of time on a PN, smaller volumes of additionaladditives, such as vitamins, minerals, electrolytes, etc., are alsoprescribed for inclusion in the mix.

Compounding devices facilitate the preparation of PN mixtures inaccordance with the instructions provided by a medical professional,such as a doctor, nurse, pharmacist, veterinarian, nutritionist,engineer, or other. Compounding devices typically provide an interfacethat allows the medical professional to input, view, and verify thedosage and composition of the PN to be prepared and afterward confirmwhat had been compounded. The compounding device also typically includessource containers (i.e., bottles, bags, syringes, vials, etc.) thatcontain various solutions that can be part of the prescribed PN. Thesource containers can be hung from a framework that is part of thecompounding device or can be mounted to a hood bar that is either partof or separate from the compounding device. A single pump or a pluralityof pumps may be provided which, under the control of a controller, pumpthe selected solutions into a final container, for example, a receivingbag. The receiving bag is typically set on a load cell while beingfilled so that it can be weighed to ensure that the correct amount ofsolution is prepared. Once the bag has been filled, it can be releasedfrom the compounding device and, in this exemplary embodiment, can beused as a reservoir for intravenous infusion to a patient. Compoundingdevices are typically designed for operation in aseptic conditions whencompounding pharmaceutical or neutraceutical ingredients.

When pharmaceuticals are used, a pharmacist can review instructions thatare sent to the compounding device to ensure an improper mixture doesnot occur. The pharmacist can also ensure the specific sequencing offluids/liquids is appropriate.

In the medical field, compounding devices can be used to compound fluidsand/or drugs in support of chemotherapy, cardioplegia, therapiesinvolving the administration of antibiotics and/or blood productstherapies, and in biotechnology processing, including diagnosticsolution preparation and solution preparation for cellular and molecularprocess development. Furthermore, compounding devices can be used tocompound fluids outside the medical field.

Recently, there have been efforts to provide a compounding device thatcan operate more efficiently, with less downtime during source containerreplacement, and with increased usability features promoting moreintuitive use of the system, as well as bubble and/or occlusion sensormechanisms that cause fewer nuisance alarms.

SUMMARY

Accordingly, it may be beneficial to provide a compounding device,system, method, kit or software that operates more efficiently, improvesset up time, and reduces downtime when an ingredient runs out and needsreplacement, and which provides an aesthetically pleasing andintuitively operational structure, method of set up and use, and anassociated usable, efficient and aesthetically pleasing computerinterface. Certain embodiments of the disclosed subject matter alsoincrease accuracy at small dispensed volumes, provide a form factor thatpromotes easier cleaning/disinfecting to maintain aseptic conditions,and also prevent errors, especially in transfer set/fluid pathconnections.

According to one aspect of the disclosure, a manifold for a compoundingdevice can include a housing, at least one primary intake port locatedon the housing and including a primary valve configured to open andclose the at least one primary intake port to permit or refuse passageof at least one primary ingredient through the manifold, a plurality ofsecondary intake ports located on the housing, each of the secondaryintake ports including a secondary valve configured to open and close arespective one of the plurality of secondary intake ports to permit orrefuse passage of a plurality of secondary ingredients through themanifold, a first channel in fluid communication with the at least oneprimary valve and including an outlet port configured to outlet the atleast one primary ingredient from the manifold, and a second channel influid communication with the plurality of secondary valves and includingan outlet port configured to outlet at least one of the plurality ofsecondary ingredients from the manifold, wherein the first channel andsecond channel are in fluid isolation from each other such that the atleast one primary ingredient does not mix with the plurality ofsecondary ingredients within the manifold.

According to another aspect of the disclosure, a transfer set for acompounding device can include a housing, at least one primary flexibleinput line connected to the housing via a primary valve configured topermit or refuse passage of at least one primary ingredient from the atleast one primary flexible input line through the housing, a pluralityof secondary flexible input lines connected to the housing via at leastone secondary valve configured to permit or refuse passage of aplurality of secondary ingredients from the secondary flexible inputlines through the housing, a first channel defined by the housing and influid communication with the at least one primary flexible input lineand including an outlet port configured to outlet the at least oneprimary ingredient from the housing, a second channel defined by thehousing and in fluid communication with the plurality of secondaryflexible input lines and including an outlet port configured to outletthe plurality of secondary ingredients from the housing, at least oneprimary flexible output line connected to the outlet port of the firstchannel, the housing configured such that the at least one primaryingredient is transported away from the housing via the at least oneprimary flexible output line during use of the transfer set, and atleast one secondary flexible output line connected to the outlet port ofthe second channel, the housing configured such that the plurality ofsecondary ingredients are transported away from the housing via the atleast one secondary flexible output line during use of the transfer set.

According to yet another aspect of the disclosure, a method for using atransfer set with a compounding device can include providing thetransfer set that includes a housing with at least one primary intakeport and at least one secondary intake port, a first flexible outputline extending from the housing, and a second flexible output lineextending from the housing, providing the compounding device thatincludes a housing, a first pump, and a second pump, connecting thehousing of the transfer set to the housing of the compounding device,leading the first flexible output line onto the first pump to attach thefirst flexible output line to the first pump, and leading the secondflexible output line onto the second pump to attach the second flexibleoutput line to the second pump.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed subject matter of the present application will now bedescribed in more detail with reference to exemplary embodiments of theapparatus and method, given by way of example, and with reference to theaccompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary embodiment of a compoundingsystem made in accordance with principles of the disclosed subjectmatter.

FIG. 2A is a perspective view of the exemplary transfer set of FIG. 1 .

FIG. 2B is a partial perspective view of the exemplary embodiment ofFIG. 1 .

FIGS. 3A-G are partial perspective views of the exemplary embodiment ofFIG. 1 in sequential positions in which an exemplary transfer setincluding manifold and output lines are aligned and connected toexemplary valve actuators, sensor block and pumps.

FIG. 3H is a side view of the platen lock shown in FIGS. 3A-3F.

FIG. 4A is a top view of an exemplary manifold, strain relief, unionjunction, and output line made in accordance with principles of thedisclosed subject matter.

FIG. 4B is a perspective exploded view of the structures shown in FIG.4A.

FIG. 5 is a partial perspective view of the strain relief shown in FIG.4A.

FIGS. 6A-C are cross section views taken along lines 6A, 6B, and 6C ofFIG. 4A, respectively.

FIGS. 7A-C are a bottom, perspective exploded, and perspective assembledview, respectively, of the manifold of FIG. 1 .

FIG. 8A is a cross-section taken along line 8A-8A of FIG. 8B.

FIG. 8B is a side view of the valve shown in FIG. 7B.

FIG. 9 is a cross-sectional view of two exemplary micro valves and twomacro valves in open and closed positions and located in a valve housingin the manifold of FIG. 1 .

FIG. 10 is a top perspective view of an exemplary union junction.

FIG. 11 is a bottom perspective view of the exemplary union junction ofFIG. 10 .

FIG. 12 is a top view of the exemplary union junction of FIG. 10 .

FIG. 13 is a partial perspective view of a compounding system made inaccordance with principles of the presently disclosed subject matter.

FIGS. 14A and 14B are partial perspective views of the bag tray andreceiving bag.

FIG. 15 is a right rear corner perspective view of a front/top panel andsensor array for the compounding system of FIG. 1 .

FIGS. 16-34 are screen shots of an exemplary controller interface foruse with a compounding device or system made in accordance withprinciples of the disclosed subject matter.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIGS. 1 and 2B are two different perspective views of an exemplaryembodiment of a compounding system 1 made in accordance with principlesof the disclosed subject matter, with safety lids which are alsohereinafter referred to as a sensor bridge cover 10 f and a pump cover10 g in a closed position and opened position, respectively. The system1 can be used to compound or combine various fluids from small or largecontainers 4 a, 4 b and consolidate the fluids into a single/finalcontainer, such as an intravenous fluid bag 80, for delivery to a humanor animal patient, or to a lab for diagnostics, or to a storage facilityfor later sales or use. In one example, the system 1 can include aplurality of small supply containers 4 a and large supply containers 4 beach attached to an ingredient frame 3, a housing 10 having at least onepump (41, 42) (See FIG. 3A), a transfer set 2 (See FIG. 2A) that isselectively connectable to the housing 10 and that includes a manifold20 attached to a plurality of micro input lines 2011, macro lines 2021,a controller connection 90, a controller 2900, and a discharge tray 70in which a final container, such as IV fluid bag 80, can rest whileconnected to an output line(s) of the transfer set 2. The transfer set 2is intended to be a sterile, disposable item. In particular, thetransfer set 2 can be configured to create or compound many differentmixtures or prescriptions into appropriate receiving bags 80 for apredetermined time or predetermined volume limit. Once the transfer set2 reaches its predetermined time and/or volume limit, the set 2 can bedisposed of and replaced by a new transfer set 2. In other words, thetransfer set 2 is a pharmacy tool that is to be used for a fullcompounding campaign, for example, for a 24 hour compounding run inwhich prescriptions for multiple patients are filled during that timeperiod. Before beginning a given compounding procedure, the operatorloads the various components of the transfer set 2 to the housing 10 ofthe compounding device 1.

As shown in FIG. 1 , the transfer set 2 (See FIG. 2A) can be connected(or connectable) between the at least one input container (such as microcontainer(s) 4 a and/or macro container(s) 4 b) and the output container(such as an IV fluid bag 80) via a plurality of lines (for example,micro input line(s) 2011 and/or macro line(s) 2021). The transfer set 2can include a plurality of micro and macro lines 2011, 2021 extendingtherethrough, a manifold 20, a strain relief clip 33, a union junction60 and an output line 2031. The micro and macro lines 2011, 2021 runthrough at least one manifold 20 such that fluids from each of theseparate supply containers 4 a, 4 b can be at least partially mixed inthe manifold 20 prior to further mixing at junction 60 locateddownstream of pump 40. The transfer set 2 is connectable to the mainhousing 10 of the system 1 and provides the connection between the inputsupply container(s) 4 a, 4 b and the output container. The housing 10provides (among other features) pumping and control functionality tosafely and efficiently select and deliver exact quantities of variousfluids from containers 4 a, 4 b through the transfer set 2 to the outputcontainer. The manifold 20 can include two separate flow paths such thatcompounding can continue along a first flow path while the second flowpath is interrupted.

The transfer set 2 macro lines 2021 and micro lines 2011 are allattached to specific inlet tubing ports (i.e., 20 a and 20 b) of themanifold 20. The free or upstream ends of these lines are each uniquelymarked with a permanent identification tag 802. In this exemplaryembodiment, the identification tag 802 is a bar coded flag or sticker.The identification tag 802 provides one-to-one traceability andcorresponds to a specific instance of the inlet tubing port (20 a or 20b) to which it is attached. The source containers 4 a and 4 b possessunique data identifying the type and kind of fluids contained therein.This data can also be formatted in bar code format and placed onto tag801. During use, the attached source containers (i.e., 4 a and 4 b) canbe linked in the controlling software to the specific lines 2011 or 2021by linking the source container data on the bar code format located ontag 801 to the bar code (or other identification information) located onthe attached line identification tag 802. Once connected, correlated andlinked in this way, when the compounding device requires the specificingredient, the software links established above determines which valveactuator 102 a′ or 102 b′ must be turned in order to introduce therequired or intended source fluid into the compounded receiving bag 80.

Connection of the transfer set 2 to the main housing 10 can be initiatedby connecting the manifold 20 to the housing 10. The manifold 20 caninclude a plurality of ports, such as micro input line port(s) 20 aand/or macro input line port(s) 20 b. The lines of the transfer set 2can include a plurality of lines, such as micro lines 2011 and/or macrolines 2021 and/or combination micro/macro line(s) referred to as flexline(s). The plurality of lines can correspondingly connect to theabove-referenced micro container(s) 4 a and/or macro container(s) 4 b atan input end of respective micro and macro line(s) 2011, 2021. An outputend of each of the micro and macro line(s) 2011, 2021 can be connectedto the manifold 20. The manifold 20 can be selectively connected to thehousing 10 such that at least one valve 21 a, 21 b located in themanifold 20 can be aligned with a valve actuator 102 a′ and 102 b′ thatcan be incorporated in a stepper motor 102 a, 102 b located in thehousing 10 (which will be described in more detail below).

In this exemplary embodiment, as shown in FIGS. 3A and 3B, wheninstalling the transfer set 2 onto housing 10, the manifold 20 isconnected to a top left side of housing 10 within a shallow tray indent10 c in the upper surface of the housing 10. The shallow tray 10 callows spilled fluids or leaks to run off the pump housing 10 in orderto prevent ingress of the fluids to the internal electronics andmechanisms of the compounding system 1. In FIG. 3A, transfer set 2 andmanifold 20 are not yet in position and are located above the housing 10as if a user is starting the process of placing the transfer set 2 ontothe housing 10 and preparing for use of the compounding system 1. Thetransfer set 2 includes a manifold 20 that has two distinct channels: afirst channel 24 a that connects to a plurality of micro lines 2011and/or macro lines 2021, and a second channel 24 b that connects to aplurality of macro lines 2021. Of course, in other embodiments the firstand second channels could each be connected solely to micro, macro,flex, or other types of lines, respectively, or could be connected tocombinations of micro, macro, or other types of lines. The first channel24 a and the second channel 24 b are located in the manifold 20 and canbe completely separate from each other (i.e., in fluid isolation fromeach other), such that no fluid from the first channel 24 a mixes withfluid from the second channel 24 b. The channel is considered thatportion or area in the manifold through which fluid can flow. In thisembodiment, a micro outlet 25 a and a macro outlet 25 b can be locatedon a downstream side of manifold 20 and connected to micro line 2011 andmacro line 2021, respectively. It should be noted that the linesdownstream of the manifold (e.g., outlet lines, or micro line 2011 andmacro line 2021) can incorporate different tubing as compared to theinlet lines 2011, 2021 that supply fluid to the manifold 20. Forexample, the inlet lines can include tubing made of more or less rigidmaterial as compared to the outlet lines, and can also include tubingmade with larger or smaller diameter openings, or made of larger orsmaller side wall thicknesses. In addition, the color of the inlet linescan be different from the color of the outlet lines, and the lines canalso have different surface textures either inside or outside of thetubing. For example, the texture on the inside could be configured topromote or prevent turbulence, depending on the application and locationof the line.

A sensor structure 29 can be located in the manifold (See FIGS. 7A and7B) and is configured to trip a sensor 2901 (See FIG. 15 ) located inthe housing 10 that tells the system that the manifold 20 is in acorrect/operational position. Alternatively, the sensor 2901 can beconfigured to confirm the presence and gross positional information forthe manifold 20, but not necessarily configured to confirm that theposition is fully operational. The sensor structure 29 can include amagnet 29 m that goes into a housing 29 h and provides a signal to (oractuates) the sensor 2901 in the housing 10 which indicates thatmanifold 20 and transfer set 2 are properly (i.e., securely) in place(See FIG. 7A). Software used with the system can be configured such thatthe compounder 1 will not operate/function when sensor 2901 does notsense or is not actuated by the magnet 29 m (i.e., when the manifold 20is not in proper position with respect to the housing 10). After themanifold 20 is secured to the housing by clips 27 a, 27 b located onopposing ends of the manifold 20 (See FIG. 2B), a strain relief clip 33can be seated onto the housing. The strain relief clip can bepre-assembled and attached to both the micro line 2011 and macro line2021. When installed, the strain relief can be placed to the right andimmediately adjacent a sensor bridge 10 e that forms a right wall of theshallow manifold tray indent 10 c in which the manifold 20 is seated.The strain relief clip 33 can be pre-assembled to the transfer set 2 toensure ease of use by the end user.

As shown in FIG. 3C, once the manifold 20 is attached to the housing 10and the strain relief clip 33 is in place, the sensor bridge cover 10 fcan be closed over the sensor bridge 10 e in order to protect thesensors and strain relief clip 33 from inadvertent contact and/orcontamination from dust, liquids or other contaminants. The sensorbridge 10 e can include a sensor or sensors (for example, an ultrasonicsensor, photo sensor, or other sensor) acting as a bubble detectorand/or occlusion detector.

FIG. 3D shows an exemplary next step of installing the transfer set 2,which includes connecting the union junction 60 to the housing bysnapping clip locks 60 f (see FIGS. 10 and 11 ) located on the junction60 to mating locks formed on an upper surface of the housing 10 and tothe right of the pump 40. The output line 2031 can be set within anoutput guide 18 (See FIG. 3A) formed in an outer wall that defines asecond shallow pump tray indent 10 d in the upper surface of the housingin which the pump 40 is located.

As shown in FIG. 3E, once the junction 60 and output line 2031 are inplace, the micro line 2011 and macro line 2021 can be seated within theperistaltic pump 40. Alternatively, the union junction 60 can also besnapped into place after installing the pump tubing around each rotor41, 42. In particular, micro line 2011 can be placed about the outerperiphery of first rotor 41 and macro line 2021 can be placed about theouter periphery of second rotor 42. In this position, the micro line2011 will be located between the first/micro rotor 41 and thefirst/micro platen 43 a, and the macro line 2021 will be located betweenthe second/macro rotor 42 and the second/macro platen 43 b.

FIG. 3F shows an exemplary next step for connecting the transfer set 2to the housing 10, which includes rotating the first/micro platen lock44 a clockwise to lock the platen 43 a at its closed position relativeto the first rotor 41, and rotating the second/macro platen lock 44 bcounter-clockwise to lock the second platen 43 b at its closed positionrelative to the second rotor 42. In this position, when the rotors 41and 42 are actuated and when any one of the valves 21 a, 21 b arerotated to the open position, each of the rotors will draw fluid(s)through respective lines 2011, 2021 through peristaltic forces/actions.If one of the valves 21 a or 21 b is not opened and the pump rotoroperates, the peristaltic forces will create a vacuum between themanifold channels 24 a, 24 b inside the micro lines 2011 or macro lines2021 between the manifold 20 and the pump rotors 41, 42 possiblyresulting in an occlusion of the affected line. The occlusion will bedetected as the wall of the micro lines 2011 and macro lines 2021 willpartially collapse and this will be measured by the occlusion sensorwithin the sensor bridge 10 e. The occlusion sensor 33 o can be anoptical sensor, a force based sensor, pressure sensor, an ultrasonicsensor or other known sensor for determining whether an occlusion hasoccurred in the line. In another embodiment, an occlusion sensor 33 oand a bubble sensor 33 b can be incorporated into the sensor bridge 10e. Alternatively, a combined sensor 33 o/b or sensors 33 o, 33 b can beincorporated into the strain relief 33, or at other locations along thesystem 1, and can be integrated into the strain relief 33 or bridge 10 eor can be separate and independent structures that are attached to thesystem 1.

FIG. 3G shows an exemplary final step in the setup of the system 1, inwhich the pump cover 10 g is closed over the pump 40 to protect the pump40 from contact with other devices/structures/persons and to protect thepump 40 and associated lines 2011, 2021 from contamination from dust,liquids, or other contaminants. Each of the sensor cover 10 f and pumpcover 10 g can include a magnet or other type of sensor or lockingmechanism to ensure the covers are in place during operation of thesystem 1.

Once the transfer set 2 is correctly connected to the housing 10,input/storage containers 4 a, 4 b, and receiving bag 80, and the covers10 f and 10 g are closed, calibration of the system 1 and thenprocessing and compounding of various fluids can take place.

FIG. 3H depicts an exemplary embodiment of a platen lock 44 a. Theplaten lock 44 a can be configured to rotate about a rotational axis andcause a cam 444 to come into resilient contact with the platen 43 a. Thecam 444 can include a biasing member, such as, for example, a spring443, including, but not limited to, a plate spring, coil spring, orother type of spring to cause the cam 444 to keep in constant contactwith and apply a preset and constant force to the platen 43 a, which inturn keeps a constant or preset force on the micro line 2011 locatedbetween the platen and the rotor 41 to ensure accurate and predictablevolumetric output by the pump 40 over the life of the transfer set. Thespring 443 can be an important factor in the wear of the tubing linesduring compounding, which can also impact the output of the pump 40.

Accuracy can also be a function of pump tubing inner diameter, tubingwall thickness, and the spacing between rollers and platen. Accuracy isalso affected by the speed of rotation, but both motors can have thesame accuracy.

The platen lock 44 a can have a streamlined appearance, being configuredsubstantially as a simple, L-shaped structure with an overhang upperextension 441 and a rotational lower extension 442. The lower extensionhaving a longitudinal axis about which the platen lock 44 a rotates. Theplaten lock 44 a can be made from aluminum or other rigid material suchas plastics, ceramics and/or other metals or alloys. The simplestructure provides a user a sense of efficiency in the nature ofoperation of the platen lock structure 44 a. The lower extension 442 canbe configured with an opening to slide onto and attach to rotationalpost 449 extending from/within the housing 10. The platen lock 44 a canlock onto the post 449 via a simple friction fit, a spline typerelationship between the post 449 and the opening in the lower extension442, or other structural configuration. In an alternate embodiment, aset screw structure 445 can be provided in the lower extension 442 forquick connection to the rotational post 449 that extends from thehousing 10 of the compounding system 1. In the embodiment depicted inFIG. 3H, a set screw 445 s can be used to set the preload on the spring443 that is contained inside the platen lock 44 a, 44 b. This spring 443applies force on the platen 43 a, 43 b and ultimately squeezes theplaten 43 a, 43 b against the respective rotor 41, 42. A magnetic lockstructure 449 m and 442 m can also (or alternative to the screwstructure 445) be provided and can have multiple functions, including:locking the platen lock 44 a to the housing 10 to prevent removal of theplaten lock 44 a from the housing 10 until the magnetic locks 449 m and442 m are released. The location of platen lock 44 a with respect toplaten 43 a can be achieved by a detent position on the backside of theplaten 43 a. As the platen lock 44 a is rotated against the platen 43 atowards the lock position, the cam 444 follows a profile on the back ofthe platen which includes a raised feature to compress the cam 444,which the user has to rotate past to reach the final lock position. Theaction of the cam over this feature provides feedback to the user thatthe lock point has been reached, and mechanically maintains this lockposition due to the cam sitting in a cavity feature. Continued rotationpast the desired lock point can be prevented by providing hard stopgeometry in the platen profile such that the cam cannot get past thehard stop geometry. The location of the cam 444 when the platen lock 44a is in this lock position, is where sensor 2904 a is tripped via amagnet 446 embedded in the bottom of cam 444. The coupling of lock arm44 a to the post 449 is achieved via a pair of magnets, the first 449 membedded in the top of post 449, the second 442 m at the end of thereceiving bore in the lower extension 442 of the lock arm 44 a.

Another benefit of this exemplary embodiment of the system 1 is that theconfiguration allows the operator to easily remove the platens 43 a, 43b and platen lock components 44 a, 44 b from the pump housing forcleaning without the use of tools. Both platens 43 a, 43 b can beremoved by simply pulling them upward and away from the pump housingsurface 10 d.

In addition, both rotors 41, 42 can be removed without tools by simplyunscrewing thumb screws that can be provided at a center/rotational axisof the rotors 41, 42. Because the rotors 41, 42 can be interchangeable,their life can be extended by swapping their positions after cleaning,e.g., macro to micro and micro to macro.

The pump 40 can include rotors 41, 42 that are each mounted upon andseparately rotated by a respective stepper motor 41 s, 42 s (See FIG.3F). Each of the stepper motors 41 s, 42 s can have a preset microstepsper revolution value that is relatively high (for example, on the orderof 10³ greater than the microsteps per revolution value for the steppermotors 102 a, 102 b used to rotate valves 21 a, 21 b located in manifold20, as described in more detail below). The high value of microsteps perrevolution for the stepper motors 41 s, 42 s allows for greater accuracyor precision in fluid delivery for the system 1. Each of the steppermotors 41 s, 42 s can be connected to controller 2900 and can beseparately, sequentially, serially, concurrently or otherwise controlledto cause each of the rotors 41, 42 to rotate a known and predeterminedamount and possibly at a predetermined speed such that a highly accurateamount and timing of material flow through the compounding device can beachieved. In addition, steppers 41 s, 42 s can be provided with absoluteencoders that are in communication with controller 2900 to provideexplicit positioning control of the steppers 41 s, 42 s.

The rotors 41, 42 can be substantially identical to each other such thatthey can be interchanged. For example, in one embodiment, the macrorotor 42 can be configured to rotate more than the micro rotor 41 andwill thus be subject to higher wear. Thus, at some point during a breakin operation of the compounding system 1, the macro rotor 42 can beinterchanged with the micro rotor 41 such that the rotor 41 will act asthe macro rotor and be subject to the heightened wear for a time period.In this manner, the life of both rotors 41, 42 can be extended.

The cam 444 and the spring 443 can also be configured to provide a knownforce to the platen 43 a when the platen lock 44 a is in a certainrotational position such that the platen lock 44 a is effectively lockedin place due to both resilient forces and frictional forces that occurwhen at the certain position relative to the platen 43 a. In otherwords, once the platen lock 44 a passes a predetermined rotationalposition, resilient force acting on the platen lock 44 a by the platen43 a tends to cause the platen lock to continue its clockwise rotation.A sensor, such as a magnet 446, can be provided in the platen lock 44 aand configured to trip a corresponding sensor 2904 a in the housing 10that tells the system the platen lock 44 a is in the correct position.However, if there is a rotational stop located in either the post in thehousing or the lower extension 442, the platen lock 44 a will be unableto rotate further in the clockwise rotational direction and will simplymaintain the above-referenced known resilient force (due to cam 444 andcam spring 443) with the resilient force also acting to prevent releaseof (counterclockwise rotation of) the platen lock 44 a. Unlocking theplaten lock 44 a from the platen 43 a in this case would simply requirethe operator to overcome the resilient and frictional forces of the camin the detent position tending to hold the structures in place. Itshould also be noted that the platen lock 44 b and platen 43 b can beconfigured in a similar manner as described above with respect to theplaten lock 44 a and platen 43 a, except that locking would occur in acounterclockwise rotational motion.

FIGS. 4A and 4B show a portion of an exemplary transfer set 2 thatincludes a manifold 20 connected via micro line 2011 and macro line 2021to a strain relief clip 33. Micro line 2011 and macro line 2021 extendpast the strain relief clip 33 and eventually combine or merge at theunion junction 60, resulting in a single outlet line 2031 for thetransfer set 2. The macro lines 2021 can be portions of the samecontinuous tubing structure. By contrast, in this example, micro lines2011 are separate structures joined together by shunt 33 g. The shunt 33g can be made from a material that is harder than the micro lines 2011.For example, the micro lines 2011 can be made from silicone tubing whilethe shunt 33 g can be made from a relatively more rigid PVC material.The shunt 33 g provides extra rigidity such that the strain relief clip33 can connect securely thereto without causing the inner diameter ofthe shunt 33 g to be squeezed or otherwise reduced. One or more collars33 d can be provided on the shunt 33 g to lock to the clip 33 andprevent the shunt 33 g from moving along a longitudinal axis of themicro lines 2011. Additional collars are contemplated so thatmanufacturing can be easier with respect to consistentlylocating/assembling of the manifold set structures. By contrast, themacro line 2021 can be sufficiently large enough in diameter andthickness such that its inner diameter is not squeezed or reduced whenthe clip 33 is attached thereto. Thus, when the strain relief clip 33 isattached to the micro lines 2011 and macro line 2021, the clip 33 doesnot significantly change the inner diameter characteristics for thelines while preventing forces acting along the longitudinal axes of thelines from being transmitted past the clip 33. Thus, when the micro line2011 and macro line 2021 are connected about a respective rotor 41, 42of the peristaltic pump 40, the rotary forces acting on the lines do nottranslate along the micro and macro input lines back towards themanifold 20 and the bubble and occlusion sensors. The strain relief clip33 acts as a damper to minimize transmission of linear forces andvibrations from the pump 40 to the manifold 20. Minimizing these forcesand vibrations optimizes the functionality of the bubble and occlusionsensors which would otherwise be impacted by changes in tubing tensionas the tubing is pulled by the peristaltic action of the pump.Similarly, the strain relief provides a fixed position on the set 2relative to the manifold 20 to facilitate installation of the tubing orline segments through the occlusion and bubble sensors 33 o, 33 b, 33o/b and maintains a repeatable tension on these line segments.

The strain relief clip 33 can be of various shapes, and in theembodiment shown in FIG. 5 the clip 33 is configured as a two piece clamshell type design in which an upper portion 33 a can be attached to alower portion 33 b by clips 33 i that are integrally formed at locationsabout a perimeter of each portion 33 a and 33 b, and mate with snaplatch receptacles 33 j in an opposing portion 33 a, 33 b. Throughways 33c can be formed as half cylindrical cutouts in the upper portion 33 aand lower portion 33 b. A guide sleeve 33 h can be provided at a cornerof one of the clam shell portions 33 a, 33 b to guide the opposing claimshell portion 33 a, 33 b into engagement when coupling the clam shellportions 33 a, 33 b. The micro line 2011 and macro line 2021 can passthrough these throughways 33 c and be locked to the strain relief clip33 by a series of ridges 33 r that connect to mating ridge 33 s in theshunt 33 g and/or to the macro line 2021 itself. It is possible that thestrain relief parts 33 a and 33 b are in fact identical so that theabove described process and configuration is possible with the use oftwo instances of the same component.

FIGS. 6A-6C show various cross-sections of the exemplary manifold 20 ofFIG. 4A without valve structures located therein for clarity. The crosssection shown in FIG. 6A depicts two sets of ports: two macro ports 20 band two flex ports 20 bf that are each cylindrical in shape and are influid communication with a valve housing 20 bh and 20 bfh, respectively,located immediately underneath the ports 20 b and 20 bf. The ports 20 band 20 bf are configured such that a macro line 2021 can be slid intothe inner periphery of the upward and outward facing cylindrical openingin the ports 20 b and 20 bf for attachment thereto. Thus, the ports 20 band 20 bf can be connected to various macro source containers 4 b viathe lines 2021 attached to the ports 20 b and 20 bf. A valve 21 b, 21 a(to be described in more detail below) can be located within the valvehousing 20 bh, 20 bfh, respectively, located beneath the ports 20 b, 20bf. When the valve 21 b, 21 a is located in the housing 20 bh, 20 bfh,the valve 21 b, 21 a selectively connects the fluid located in line 2021with the fluid located in channel 24 b, 24 a of the manifold dependingon the valve's rotational position within the housing 20 bh, 20 bfh.

The manifold described above can, in the exemplary embodiment, be formed(e.g., molded) as one unitary structure 20 including all of the features20 a, 20 b, 20 bf, 20 ah, 20 bh, 20 bfh, 24 a, 24 b, 25 b, 26, 27 a, 27b, and 29. Also, it is possible to join any or all separate structures(components) 20 a, 20 b, 20 bf, 20 ah, 20 bh, 20 bfh, 24 a, 24 b, 25 b,26, 27 a, 27 b, and 29 in any combination into a manifold assembly 20 toachieve the same purpose.

FIGS. 7A-C show a bottom view of the manifold 20, an exploded view, andan assembled view, respectively. The manifold 20 includes an array ofmacro ports 20 b located in a linear fashion along either side of secondchannel 24 b. The first channel 24 a includes both flex ports 20 bf andmicro ports 20 a located along the length thereof and provides fluidcommunication therebetween. Thus, the first channel 24 a can beconnected to both a macro flex line 2021 and a micro line 2011. In thisembodiment, the flex line is configured as shown in FIG. 1 as a firstmacro line 2021 that is joined at a junction 2071 to two outgoing macrolines 2021 to allow fluid from macro container 4 b to be supplied toboth the first channel 24 a and second channel 24 b. In other words, ajumper branch connection in a macro line 2021 can be provided such thatthe macro line 2021 branches in two directions after leaving the macrostorage container 4 b, and can be connected to both the second channel24 b and the first channel 24 a. The flex line conducts the samefluid/solution (e.g., nutritional ingredient) from container 4 b to bothchannels 24 a and 24 b of the manifold 20 after passing through thevalves 21 bf and 21 b, respectively. This facilitates the option of asingular or larger source container 4 b being used for purposes offlushing/clearing the channels 24 a and 24 b as opposed to two separatecontainers 4 b, wherein one container is connected to channel 24 a and aseparate other container is connected to channel 24 b. A plurality offlex lines can be used since multiple types of flushing ingredients maybe required during a compounding campaign depending on the varyingclinical needs of the intended final contents of sequentially filledreceiving containers (e.g. final bags 80). It should be noted that inthis embodiment flex lines are terminated at flex ports 20 bf (See FIG.6B) farthest along the channels 24 a and 24 b from the outlets 25 a and25 b, thereby allowing the entire channels 24 a and 24 b to be flushedwith the flushing ingredient. In this embodiment, the micro line 2011 isnot branched after leaving the micro storage container 4 a, andtherefore, there are no micro ports 20 a that communicate with thesecond channel 24 b. It is contemplated that an embodiment of thedisclosed subject matter could include a manifold configured with valvesadapted to allow micro lines to be attached to both the first and secondchannels 24 a and 24 b. Flex lines are designed to be used for anyingredient which may be requested across a wide range of volumes amongdifferent patient prescriptions. Hence, for some prescriptions wherethey are requested in small volumes, they can be delivered by the micropump. Similarly, for prescriptions where they are requested in largevolumes, they can be delivered by the macro pump. The y-connection fluidpath of the flex line gives the ingredient access to both fluid paths(micro and macro) therefore the system can decide which pump to use todeliver that ingredient appropriately based on the requested volume.

In FIG. 7B, the valves 21 a, 21 b and filler 200 are disassembled tobetter show their relationship with the macro valve housing 20 bh, microvalve housing 20 ah, and first channel 24 a in which each of thesestructures resides when assembled and ready for use. As can be seen,each of the valves 21 a and 21 b include a keyway 21 a 4 and 21 b 4,respectively, that allows for positive attachment to an actuator member102 a′ and 102 b′ that extends from a manifold indent/surface 10 c inthe housing 10 of the compounding device.

The operational valve structures are in fact combinations of therotating members (valves 21 a and 21 b) and the inner diameter (ID) ofthe socket in the manifold (20 ah and 20 bh) in which the valves 21 a,21 b are located. The configuration of the operational valve structureswas intended to create a more moldable elastomeric valve in which, understatic fluid conditions, gravity based movement of fluids (like themotion caused by fluids of differing densities or different specificgravities settling or rising when the valve is left open) can beprevented or limited.

The actuator member is controlled by at least one stepper motor 102 a,102 b such that rotation of the valves 21 a and 21 b can be precise. Inone embodiment, the stepper motor 102 a for the micro valves 21 a can beof higher precision than the stepper motor 102 b for the macro valves 21b (See FIG. 9 ). Higher precision stepper motors can be used to providethe positional accuracy of the micro valves 24 a due to the inherentflexibility of the micro valves 24 a. For example, a stepper that has apreset value of about 48 microsteps per revolution can be used (whichpreset value can be on the order of 10³ less than the microsteps perrevolution value for the pump). Accuracy of the valves 21 a, 21 b (i.e.,precise movement of the valves 21 a, 21 b) can be further controlledthrough the use of a tall gear box, which would result in large inputrotations for the stepper motors 102 a, 102 b providing for smallmovement of each of the valves 21 a, 21 b, respectively. The flexibilityof material that makes up each of the valves 21 a, 21 b can beconfigured or selected to enhance or provide improved sealing surfaceswhich withstand pressure differentials without leaking. Given thistorsional flexibility and considering the friction opposing rotation ofthe micro valve 24 a, it follows that during rotation, the upperfeatures of the valve, i.e., those opposite the drive slots 24 a 4,angularly lag behind the lower features of the valve. Thus, in order toproperly place the fluid opening between the valve 24 a and the channel21 a, the higher precision stepper motors first rotate the valve 24 a sothat the top of the valve is properly positioned, and then reversedirection to bring the lower features also into proper position andtherefore straightening the valve. The same action returns the valve tothe closed position. The rotation of the steppers 102 a and thereforethe actuators 102 a′ and the valve 24 a, can be clockwise,counter-clockwise, or any combination of these directions. Because, themicro valves 21 a typically control the smaller volume ingredients, thevolume should be measured and distributed with relatively higheraccuracy as compared to that of the macro valves 21 b which typicallydistribute large volume ingredients in which high accuracy is easier toachieve. However, it should be understood that accuracy of delivery isnot necessarily a direct function of valve operation. As long as thevalves are properly opened and closed, the pumps 41, 42 can be used toprovide accuracy of amount and control of fluid delivery.

In operation, the micro valves 21 a and macro valves 21 b can bedescribed as being overdriven by the stepper motors past the ‘open’position since the valves are flexible and the top of the valve lagsbehind the bottom of the valve when rotated. Thus, to properly open thevalve, the bottom of the valve is overdriven from the target angularposition. Once the top has achieved a proper location, the stepperreverses and brings the bottom of the valve into proper position. Thisoperation effectively twists and then straightens the valve, and occursin both the opening and closing process for the valves 21 a, 21 b.

FIGS. 7C and 9 show the valves 21 a, 21 b and filler 200 in place in themanifold 20. The filler 200 takes up volume within the first channel 24a such that the cross sectional area of the first channel 24 a takennormal to a longitudinal axis of the channel 24 a is smaller than thecross sectional area of the second channel 24 b taken normal to alongitudinal axis of the channel 24 b. Thus, the inner periphery of thefirst channel 24 a and second channel 24 b can be similarly shaped,allowing for certain architectural benefits in placement of the valves21 a, 21 b and in fluid flow geometry of the channels 24 a, 24 b. Thefiller 200 can include a filler rod 201 that includes a plurality ofspacers 202 located along the rod 201 so as to keep the rod 201 centeredwithin the channel 24 a. A clip lock 203 can be provided at a proximallocation of the rod 201 and configured to lock with a mating clip lockindent in the manifold 20. In particular, a flexible tab 203 a can belocated on the lock 203 and configured to mate and lock with opening 203b in manifold 20 (See FIG. 7C). A sealing member 204, such as an O-ring204, as shown in FIG. 7B, can seal the filler 200 in the socket 26 toprevent fluid such as air or liquids from leaking into or out of thechannel 24 a via the socket 26 when the filler 200 is located therein.The sealing member 204 can be located in an indent or receiving groove204 a on the rod 201 to lock the sealing member 204 in place withrespect to the filler 200. One function of the filler 200 is to reducecommon volume in channel 24 a, which reduces priming volume and flushingvolume. Because the micro pump only achieves limited flowrates, thelarge cross section of channel 24 a without the filler would bedifficult to be flushed of residuals.

Placement of the filler 200 in the channel 24 a has the added benefit ofincreasing (or otherwise controlling and directing) turbulence withinthe channel 24 a, and thus increases maximum fluid velocity within thechannel 24 a, permitting faster and more thorough flushing of residualfluids in the channel 24 a to output 25 a. The filler 200 can beconveniently loaded into the manifold via socket 26 during the time themanifold assembly 20 is being manufactured. The filler 200 geometry,particularly at the downstream end, is designed to promote flushing andto avoid areas where residual fluid can hide out and not flush properly.

Each of the micro and macro valves 21 a and 21 b can be configured as arotational type valve that, when rotated a set amount, permits acorresponding or known amount of fluid to bypass the valve. In oneembodiment, the valves 21 a, 21 b can be configured such that rotationof each of the valves does not move fluid, and only opens/closes a fluidpath. The amount of fluid that bypasses the valve can, however, beultimately determined by the pump speed, size and in conjunction withthe tubing size when using a peristaltic pump. The valves can beconfigured to simply open or close the fluid lines. FIG. 8A shows amacro valve 21 b that includes an inlet 21 b 1 at a top of the structureand an outlet 21 b 3 at a side wall of the structure. Thus, fluid entersthe top of the valve 21 b along a rotational axis of the valve 21 b, andexits a side of the valve 21 b in a direction substantially normal tothe rotational axis of the valve 21 b. Rotation of the valve 21 b isaccomplished by connection to a stepper motor 102 b via actuatorconnection slot 21 b 4 located in a bottom surface of the valve 21 b.The slot 21 b 4 acts as a keyway for a corresponding projection 102 b′extending from the top of the stepper motor 102 b. When the steppermotor 102 b turns the projection 102 b′ a preset amount, the valve 21 bis also caused to turn the same amount due to the connection between theprojection 102 b′ and the keyway or slot 21 b 4. When the valve 21 b islocated in an open position or a semi open position, fluid can travelfrom the inlet 21 b 1 down through a center of the valve 21 b until itpasses wall 21 b 2, which can be configured as a gravity wall, orP-Trap, or similar structure. After passing the wall 21 b 2, the fluidthen changes directions by approximately 180 degrees and moves up andover the outlet wall in the manifold 20 to be distributed into thesecond channel 24 b. The wall 21 b 2 and geometry and configuration ofsurrounding manifold walls prevents fluid from inadvertent anduncontrolled mixing between lines 2011/2021 and the common volume ofchannel 24 a on the micro side and between lines 2011 and the commonvolume of channel 24 b on the macro side when 1) the valve is open, 2)the fluid is static (i.e., pump rotors 41 and 42 are not moving), and 3)there exists a differential in specific gravity between the respectivefluids in the input lines and in the channels. The motivator for thisbackflow is specific gravity differences between the ingredient fluidand the fluid in the channel. This wall 21 b 2 is a technical feature ofthe valve that mechanically prevents this backflow from occurringwithout additional control mitigations, and requires no additionalsoftware/valve controls to limit the effect of this backflow tendencybecause the wall structure physically stops or prevents backflow fromhappening. Thus, the walls 21 b 2 and surrounding geometry of the valvehousing 21 bh prevents contamination of the ingredients in the supplylines and storage containers 4 b and prevents uncontrollable flow/mixinginto the channels 24 a and 24 b of the manifold 20 due to, for example,differences in specific gravity of the solutions or fluids runningthrough the valves. The output of the micro and macro valves 21 a, 21 b(with respect to each respective opening into the common channels 24 a,24 b located in manifold 20, shown in FIG. 9 ) is above theabove-described “P-trap” thus not allowing flow that might otherwiseenter into the manifold 20 due to specific gravity differences. Thus,the valves 21 a, 21 b work with the structure of the manifold 20 in thisembodiment to form the specific gravity “P-trap” structures.

Although FIGS. 8A and B show a macro valve 21 b, the micro valve 21 acan be configured and will operate in the same manner, albeit usingsmaller dimensions.

The two motors that drive each of the rotors 41, 42 can be the same, andsimilarly the rotors 41, 42 can be identical. The tubing in each channelcan be different, and the platen positions can be different because ofthe difference in the diameter and wall thickness of the tube sections.

FIG. 10 shows a perspective view of the union junction 60. The unionjunction 60 is configured to retain and/or receive a tubing structurethat includes a micro input line inlet port 60 a, a macro input lineinlet port 60 b, a union junction line 61 and an outlet port 63. Themicro input line inlet port 60 a is configured to receive the micro line2011 which carries fluid from the micro channel, which can include fluidfrom one or both the micro fluid containers and macro fluid containersthat were described earlier. The macro input line inlet port 60 b isconfigured to receive the macro line 2021 which carries fluid from themacro fluid containers that were described earlier. The micro input lineinlet port 60 a and the macro input line inlet port 60 b are bothcoupled to a junction line 61. Thus, fluid flowing from the micro line2011 enters the micro input line inlet port 60 a and flows through thejunction line 61 and is combined with fluid received by the junctionline 61 from the macro line 2021 via the macro line inlet port 60 b. Inthis manner, fluid from micro line 2011 is combined with fluid from themacro line 2021 for delivery to the receiving/final container (e.g., IVbag 80). FIG. 10 also shows macro input line tie down 60 c thatmaintains the macro input line inlet port 60 b in place. A similar tiedown 60 c can be used to secure or maintain the micro input line inletport 60 a in place. The junction line 61 includes an outlet port 63coupled to a combined fluid line 2031. As fluids from the micro line2011 and the macro line 2021 combine in the junction line 61, they flowthrough the outlet port 63 to the combined fluid line 2031. The fluidflows from the combined fluid line 2031 to the final container orreceiving bag filling station which is described in greater detailbelow. FIG. 10 also shows that the union junction 60 includes handles 60e which can be used for the placement and removal of the union junction60 onto mating receptacles on the housing 10. Locks, such as flexiblespring locks 60 f, can mate with receptacles on the housing 10 tofurther secure the junction 60 thereto.

FIG. 11 shows a bottom side perspective view of the union junction 60.FIG. 11 shows that the union junction 60 includes a plurality ofstandoff ribs 62 and pin bosses 65 which are spaced apart from eachother along an interior surface of the union junction 60. The standoffribs 62 and pin bosses 65 are configured to provide an insertion spacingstop to retain the junction 60 at a predetermined distance/heightrelative to the housing surface. The standoff ribs 62 and pin bosses 65can also provide structural integrity for the tubing structuresdescribed above, including the micro input line inlet port 60 a, themacro input line inlet port 60 b, the junction line 61 and the outletport 63 so that those structures are maintained in place even as fluidsare passed therethrough.

FIG. 12 shows a top view of the union junction 60 with the tubingstructures described above in place. As can be seen in FIG. 12 , theunion junction line 61 receives fluid via the micro input line inletport 60 a and the macro input line inlet port 60 b. The fluids mix inthe union junction line 61 and are carried to the outlet port 63 foreventual delivery to the receiving bag 80. As shown in the FIG. 12 andin this exemplary embodiment, the micro input line inlet port 60 a joinsthe union junction line 61 in a direction perpendicular to alongitudinal direction of the union junction line 61, while the macroinput line inlet port 60 b causes fluid to flow into the union junctionline 61 in the same direction as the longitudinal axis of the unionjunction line 61. In alternative embodiments, the micro input line inletport 60 a can join the union junction line 61 at any angle relative tothe longitudinal direction of the union junction line 61 so as tooptimize usability of loading onto the platform 10 d and notch 18 andsimultaneously ensure proper contact with pump rotors 41, 42 andoptimize flushability of the union junction 61.

The tubing structure described above, including the micro line inletport 60 a, the macro line inlet port 60 b, the union junction line 61and the outlet port 63 can be formed, e.g., molded, into the unionjunction 60 so as to form a unitary structure. Alternately, the tubingstructure can be formed as a separate unit that can be placed or snappedinto the union junction 60 and retained in place using a mechanism suchas the standoff ribs 62 and pin bosses 65 described above. In addition,it should be understood that the compounding device 1 can be configuredwithout the presence of a union junction 60 as shown. Instead, the unionstructure can be the final container, such as the receiving bag 80itself. For example, lines 2011 and 2021 can extend about rotors 41, 42and continue all the way to two separate ports in the receiving bag 80such that mixing of materials from lines 2011 and 2021 occurs only atthe receiving bag 80. In this case, it may be beneficial, depending onthe particular operating parameters, to secure lines 2011 and 2021 atlocations downstream of the rotors 41, 42 to ensure proper and efficientoperation of the pump 40.

FIG. 13 shows perspective view of the compounding system 1 in accordancewith an exemplary embodiment. FIG. 13 shows housing 10 located adjacenta bag tray 70 for holding a receiving bag 80 during the filling process.A load cell 71 or other device, such as an analytical balance, can beintegrated into the bag tray 70 to provide information relative to theweight and contents and to facilitate calibration as well asconfirmation of operational functions for the compounding device 1.Protective devices and/or software can be incorporated into the deviceto protect the load cell 71 or other measuring device from damage due toaccidental overload or other mishaps. As shown in FIG. 13 , the bag tray70 includes a bag tray receiving section 1350 that accommodates theshape of the receiving bag 80. The bag receiving section 1350 can beformed as a generally indented surface within the surface of the bagtray 70. The bag tray 70 also includes bag tray pins 1330 which areformed on an upper section of the bag tray 70. As shown in FIG. 13 , thebag tray pins 1330 are formed perpendicular to the surface of the bagtray 70 so as to project in a direction away from the top surface of thebag tray 70. The bag tray pins 1330 are positioned to receive and hold areceiving bag 80 for filling. FIG. 13 also shows a bag tray clip 1340which is formed along an upper section of the bag tray 70. The bag trayclip 1340 can be configured to keep a known tubing artifact constantwith respect to the fluid line(s) 2031 connected to the receiving bag 80(i.e., can be configured to dampen vibration or other force transmissionto the bag 80 and/or load cell 71). Depending on how the bag 80 isconnected to the outlet of the transfer set, and how the tube ispositioned, variances can occur. The clip 1340 prevents these variances.

FIG. 14 a shows a close up view the upper section of the bag tray 70illustrating the placement of the bag tray pins 1330 that are positionedto receive and retain a receiving bag 80 for filling. FIG. 14 a alsoshows the bag tray clip 1340 which is provided to secure the containerinput tubing, which includes the combined fluid line 2031. FIG. 14 bshows a close up view of the upper section of the bag tray 70 includinga receiving bag 80 placed in the bag tray 70. The exemplary receivingbag 80 includes two openings 1380 for receiving the bag tray pins 1330.Thus, when the bag tray pins 1330 are placed through respective openings1380 of the receiving bag 80, the receiving bag 80 is maintained inplace for filling. FIG. 14 b also shows a twist lock 1350 formed on theend of the combined fluid line 2031. The twist lock 1350 is configuredto connect to and lock with a port 1360 formed on a top surface of thereceiving bag 80. The twist lock 1350 allows the combined fluid line2031 to be securely coupled to the receiving bag 80 so that thereceiving bag 80 can be filled. The bag tray clip 1340 can be configuredto securely retain the port 1360 and twist lock 1350 that allows forquick placement, filling and removal of the receiving bag 80. The clip1340 also secures the tubing to the bag tray to prevent unwantedartifacts in the load cell 71 measurement that could occur fromexcessive motion of the tubing segment that spans the gap between thebag tray and the pump module. This tubing motion could be caused by userinteraction or pump vibration during compounding. Manual port 1390 canbe provided at the top of the receiving bag 80 such that a user caninject an ingredient that is either not included in the compoundingsystem 1 or has run out and is required to complete the receiving bag80.

In similar fashion to the description above, a dual chamber bag may befilled using a slightly modified workflow, wherein the dual chamber bagkeeps incompatible ingredients separate by two physical separatedchambers that are kept separate from each other during compounding, butare combined just before infusion of the patient is started. All of thesteps described above are followed for the ‘primary’ side of thereceiving bag. Once complete on the primary side, the primary side port1360 a is disconnected from the twist lock 1350. The secondary bag port1360 b can then be connected to the twist lock 1350 and the secondarychamber thus filled.

FIG. 15 is a rear partial perspective view of the compounding system 1that shows an exemplary sensor array used in conjunction with thesystem. Sensors 2910 can be configured to sense when the covers 10 fand/or 10 g are in place (See FIG. 3A). Alternatively, a reed switchsensor can be built into the combination sensor assembly to provideconfirmation that 10 f is closed. Sensors 2910 can be magnetic, suchthat they serve two purposes: 1) communication to a controller 2900information indicating that the covers 10 f and/or 10 g are in aclosed/operational position; and 2) securing, via magnetic force, thecovers 10 f and/or 10 g in place in the closed/operational position. Itshould be understood that the sensors themselves may not provide enoughforce to provide a hold down function. Instead, a ferrous catch plateand lid magnet can be used in conjunction with the magnetic sensor.Sensors 2904 a and 2904 b can be configured to communicate to thecontroller 2900 that the platen locks 44 a and 44 b, respectively, arein a closed/operational position. Sensor 2901 can be provided in housing10 and configured to communicate with the controller 2900 informationthat indicates that the manifold 20 has been properly affixed to thehousing 10 and is ready for operation.

Sensor 2902 can be located adjacent a rear surface of the housing 10 andconfigured to communicate with the controller 2900 information thatplaces the compounding system 1 in a service or firmware/programmingmode when a maintenance operator or technician activates this sensor(for example, by placing a magnet adjacent the sensor 2902). Thelocation of the sensor 2902 may be known only to service and technicalmaintenance personnel.

The exemplary compounding system 1 can also include a compoundingcontrol manager which resides in a central processing unit (e.g.,controller 2900). The compounding control manager allows a clinician orother healthcare or compounding professional to enter, view, adjust andoffload information pertaining to a given compounding protocol. Ingeneral, the compounding control manager is the program language thatprovides the operator with real time feedback and interaction with thecompounding device through graphical user interface (GUI) elements. TheGUI elements, created in a graphical format, display the various inputsand outputs generated by the compounding control manager and allow theuser to input and adjust the information used by the compounding controlmanager to operate the compounding device. To develop the GUI elements,the compounding control manager can utilize certain third party,off-the-shelf components and tools. Once developed, the compoundingcontrol manager can reside as a standard software program on a memorydevice.

The controller 2900 can include firmware that provides severaladjustment algorithms or hardware solutions to control the accuracy ofthe pump 40. For example, the pump output can be corrected for wear ofthe pump tubing lines 2011, 2021 over the life of the transfer set ormanifold 20. This adjustment is applied as a function of the number ofpump rotations experienced by each tubing line. The controller 2900 canalso include software or hardware such that pump output or “flow factor”can also be adjusted for the specific fluid being pumped. This “flowfactor” can account for fluid viscosity, pump speed, line type, andsource container/spike type. The controller 2900 can also be configuredto correct pump output for the rotational location of the pump rotor 41,42 rollers relative to the platens 43 a, 43 b. This adjustment can besignificant for small volumes that are dispensed and which representonly a few rotations of the pump head or less. Note that absoluteencoders can be included on both pump motors 41 s, 42 s (and valvesteppers) to provide the firmware (e.g., controller 2900) with theinformation necessary to make the above-noted adjustment(s). Thecontroller 2900 can include a bubble detection algorithm that attemptsto minimize nuisance alarms.

FIGS. 16-34 are a walk-through of display screens generated by arepresentative embodiment of the compounding control manager, whichdemonstrate various features of the compounding control manager. Afteran initial start-up mode of software initialization, a main work area iscreated on a display device, which initially opens a log-in screen. Theoperator first identifies him or herself, either by using the bar codescanner to scan an operator badge number, or by entry of a badge numberor other selected form of identification on the graphical touch screenentry pad. This identification procedure is required for logging-inand/or assessing the operator's level of security clearance. Desirably,a system administrator would have previously established a list ofauthorized users, against which the sign-in data is compared.

FIG. 16 depicts an interface that may be presented to a user after theuser has logged in and been authenticated as an authorized user. FIG. 16is a control panel that allows the user to indicate the type of transferset to be used, select the number of stations to be used and select thesource solution configuration template. The user may then be presentedwith the interface shown in FIG. 17 . The interface of FIG. 17 allowsthe user to scan a bar code located on a lid of a tray in which thetransfer set 2 is provided. In this manner, the system knows thetransfer set 2 that the user has chosen. The user can then remove thetransfer set 2 from the packaging and install it. The process ofinstalling the transfer set 2 includes opening the device doors andplatens, placing and snapping the transfer set manifold 20 to the top ofvalve actuators 102 a′, 102 b′ and platform 10 c and draping the leadsof the transfer set over a rack that is disposed in the laminar flowhood.

After the user snaps down the manifold 20 onto the device, the user maythen route the tubing through a bubble and occlusion sensor followed byclosing the sensor lid. Next, the user can route the tubing around thepump rotors and secure union junction to the pump module. Each of therotors can include a bottom flange or guide member that is configured toprevent the tubing from being installed too low or slipping or beingpinched between the pump surface and the rotor. Finally, the user canclose the platen locks and then close the pump door or cover. The useris also presented with the interface of FIG. 18 which includes achecklist of each of the tasks described above. Once each of the tasksis completed, the user can select “OK” to verify completion of thetasks. In this manner, the system ensures that the user has completedthe transfer set installation before proceeding to the next step.

The user can then initiate calibration of the load cell 71 by selectingthe “scale calibration button” shown in FIG. 19 . FIG. 20 shows afurther interface that is presented to the user to ensure that the loadcell 71 is properly calibrated. When the calibration is completed, theuser can then select the “close” button.

The user then confirms the source solutions. FIG. 21 shows an interfacethat is presented to the user for confirming the source solutions. Theuser can select the button that reads “confirm solution.” At this point,the user can select the tubing lead (i.e., micro line 2011 or macro line2021) to be confirmed and can remove a protective cap that covers thelead. The user can then attach the appropriate lead. The user can thenattach the source container to the tubing lead and hang the container onthe rack or rail. The user is then presented with the interface of FIG.22 whereby the user can scan the bar code flag 802 of the tubing leadfor the solution to be confirmed. The user can then scan the sourcecontainer bar code 801 for the solution attached to the tubing lead thatis scanned. The lot number and expiration date bar can also be scanned(FIG. 23 ).

After completing confirmation of the first container, the user canselect the “next ingredient” button shown on the interface of FIG. 24 .This allows the user to repeat the steps of FIGS. 21-23 above whichallows confirmation of all of the source solutions.

Once the source solutions have been confirmed, the user can initiate thepriming of the solutions. The user first attaches a receiving bag 80,i.e., calibration container, to the load cell 71. Then, after all of thesolutions have been confirmed, the user taps the “setup and prime” tabshown in FIG. 25 . After priming is completed, the user can select the“next” button and repeat this process for all stations. The user canalso initiate the manifold flush at this point. Next, the user caninitiate a pump calibration sequence via the interface of FIG. 26 . Theuser can then follow steps 1-5 of FIG. 26 to calibrate the pump. Thesesteps include confirming that that calibration final container isattached and marked “Not for Patient Use”; calibrate the macro pump;confirm that the macro pump is calibrated; calibrate the micro pump; andthen confirm the micro pump calibration. The user can then remove anddiscard the calibration bag.

Next, the user can install the final container (e.g., receiving bag 80).The user may be presented with the interface of FIG. 27 which allows theuser to select the option of installing the final container. The usermay then be presented with the interface of FIG. 28 which allows theuser to select a single chamber or a dual chamber receiving bag. Theuser can then scan or enter the lot number and expiration date. The usercan then attach the final container by removing the protective caps andattach the receiving bag 80 to the transfer set connector. The user canthen install or otherwise attach the receiving bag 80 by using thehanging holes formed in the container to connect to the load cell pinsand then attach the tubing inlet to the tubing clip.

At this stage, the system has been calibrated, the solutions to bedispensed have been verified and the receiving bag 80 has been installedand is ready to be filled. The user can manually program an order forthe solutions to be dispensed using the interface shown in FIG. 29 .Alternatively, the user can scan in an order or select an order from atransaction pending buffer (TPB) manager or a .PAT file. Utilizing theinterface of FIG. 29 , the user can enter all of the solution volumes tobe dispensed. Once the solution volumes have all been programmed, theuser can select the “start” tab shown in FIG. 30 . As shown in FIG. 30 ,if a solution requires a source container 4 a or 4 b change whilecompounding the next formulation, the station will display the solutionrequiring a change in yellow.

The controller 2900 can be configured to review the prescription and torequire the user to either change the sequence of the script or to add abuffer to avoid incompatibility issues in either of the common channels24 a, b (micro/macro). The pump 40 will control deliveries from each ofthe common channels by stopping one or more of the pumps 40 if theincompatible fluids would meet in the union connector 60 after the pumps40.

FIG. 31 shows a warning interface that is presented to the user when thesoftware determines that the source solution container 4 a or 4 b hasinsufficient volume. The user can then replace the container or, ifthere is some solution remaining, a manual dispense can be performed. Ifthe user chooses to perform a manual dispense, the user enters theestimated volume remaining using the interface of FIG. 32 .

In order to replace the solution, the user can remove the emptycontainer 4 a or 4 b and place a new container on the tubing lead andhang. The user can then access the interface of FIG. 33 to scan the barcode flag of the tubing lead for the new solution to be confirmed. Theuser can then scan the source container bar code for the solutionattached to the tubing lead that is scanned. The lot number andexpiration date bar codes can also be scanned. The user can then selectthe “confirm” button to complete this step.

The user can then resume compounding via the interface of FIG. 34 . Oncethe order is complete, the user can select the appropriate dispositionfor the receiving bag 80 (i.e., complete filling; scrap bag, etc.).Finally, the user can select the “apply disposition button.” Thiscompletes the compounding process and the receiving bag 80 is ready forremoval and can be used with a patient or other end user.

After all the required ingredients have been processed, the controller2900 will direct the compounder to use a universal ingredient (UI) toflush all of the ingredients out of the manifold 20 and output tubingand into final container (e.g., fluid bag 80).

The fluid bag 80 resides on a gravimetric scale 71 that provides a finalweight check back to the controller 2900 to verify that all compoundedsolutions were added. However, if a manual add of a particular componentis necessary or desired during operation, the final check by thecontroller 2900 can be overridden. The load cell 71 can also be used toaccomplish pump calibrations as well as in process calibrations, ifdesired.

The controller 2900 can include hardware or software that performscalibration of the load cell 71 and pump 40. For example, the system canbe configured to allow up to 6 verification weights to ensure the loadcell is within required accuracy. Pump calibration and in processcalibrations ensure accuracy over the life of the disposable manifold20.

The controller 2900 can also include a tube wear algorithm such thattubing wear is accounted for during the life of the manifold 20. Inother words, the timing and speed of both the valves and the pump motorscan be changed over time to account for tubing wear such that asubstantially equal volume and flow rate can be achieved by the device.

The controller 2900 can also include software and/or hardware to trackand possibly mark bags such that manual adds can be added to aparticular bag after automatic compounding. Use of a separate (possiblynetworked) control panel at a manual add station will open thecompounding event and allow the user to manually add ingredients whiletracking the fact that such ingredients were added before approving thebag for distribution to a patient or other user.

An algorithm can be incorporated into the software and/or hardware ofthe controller 2900 to determine if any bubble event requires the pump40 to stop and for the user to verify if they accept the bubble that wassensed. A flow algorithm can also be incorporated in coordination withthe use of pressure sensors to detect occlusions and/or flow pressures.Furthermore, it is conceivable that intelligent bubble handlingtechnology can be incorporated into either the controller 2900 or theocclusion or bubble sensor(s) 33 o, 33 s, 33 o/b that monitors what hasbeen delivered into the common volume (and attempts to determine a worsecase bubble event). The technology can include hardware and/or softwarethat causes the system to stop and require a user to accept or rejectthe operation depending on the presence (or lack thereof) of bubbles oran occlusion, etc. Software and/or hardware can also be provided thatdetermines whether any occlusion or bubble event, when weighed againstthe size/volume of delivery, was large enough to effect accuracy, andprovide a user with an automated or user defined option to accept orreject delivery of the end product.

The interface for the controller 2900 can include dual display ofstations that uses colors and/or numbers to identify each station. Thescreen for the controller 2900 can include a first column thatrepresents flex lines, a second and third column that represent microlines, and a fourth or last column that represents macro lines. Thescreen can group the different (in this case, three) types of stationsin order to present a clear picture of what fluids are at what stationand what type of station it is. Of course, the number and arrangement ofmicro, macro and flex lines can change depending on a particularapplication for a different embodiment of the compounding system 1.

The controller 2900 can also be configured to require ausername/password or bar coded badges to sign in/out. In addition,access can be further controlled to require username/password or barcoded badges for confirmation of required steps (e.g., addition of aningredient that requires a prescription or that is in another wayregulated).

The controller 2900 can also be configured to display a real time statusof the compounding event. For example, the controller 2900 can displaywhich solution(s) are currently being pumped from which station as wellas how much solution is left in each source container 4 a, b.

Templates can also be stored in the controller 2900 to quickly andefficiently determine the set-up and sequence of ingredients for aparticular application or a particular patient or user. A databaselocated in or accessible by the controller 2900 can include data relatedto storage, additions, removals of all drugs allowed for compounding andtheir associated data. The controller 2900 can be configured to includemultiple interfaces for the user and can be networked such that aplurality of compounding devices can be controlled and/or monitored by aseparate entity or controller. In addition, a print wizard can beincorporated into the controller 2900 software and/or hardware thatautomatically prints certain items when certain actions take place usingthe compounding device.

While certain embodiments of the invention are described above, itshould be understood that the invention can be embodied and configuredin many different ways without departing from the spirit and scope ofthe invention.

In another alternate exemplary embodiment, the occlusion sensor andbubble sensor can be positioned under the manifold common volume insteadof being located in the manifold outlet tubing. Although locating thesensor area in the common volume in the manifold may make the flushingact slightly more difficult, the location of the bubble sensor in thecommon volume can allow a user to better discriminate which source linegenerated the bubble. For example, an array of bubble sensors could belocated along the length of a common volume in the manifold toaccomplish this feature.

In yet another exemplary embodiment, the filler 200 could be removedfrom the micro common volume (e.g., first channel 24 a) and the innerdiameter of the common volume could be reduced as compared to the volumedepicted in, for example, FIG. 6B. This modification comes with certaincomplications in that manufacturing and design of the valves would bemore complicated to affect the volumetric flow rates desired in themodified first channel 24 a of the compounding device.

In another embodiment, the filler 200 could be configured with vanes onits outer diameter (OD) surface that induce turbulence and/or swirl topromote better flushing. Additionally, the filler 200 could be removablefrom the channel in order to provide an alternate flushing port.Likewise, the filler 200 could be removable such that different stylefillers (e.g., fillers having different cross-sectional shapes, sizes,number and shape of vanes, etc.) could be used in the manifold 20.

In yet another embodiment, a cross connect channel can be locatedbetween the downstream end of the micro and macro common volumes (e.g.,the first channel 24 a and second channel 24 b). A valve could beprovided to close this channel, allowing dispensing to occur as usual,and then the valve could be opened to allow the micro common volume tobe flushed by the macro pump, which operates at higher flowrates andprovide more efficient flushing.

As described above, the platen/lock arm design has springs in the lockarms that press the platens against the rotors 41, 42 when the lock arms44 a, b are closed. An alternate approach would locate torsional springsat the platen hinge points (potentially inside the instrument) such thatthe platens are always spring loaded against the rotors. The platen lockarms 44 a, b could be replaced by “platen disengagement arms” configuredto pull the platens 43 a, b away from the rotors 41, 42 during transferset installation and removal.

The pump output is a function of upstream suction pressure. To providebetter volumetric accuracy, the occlusion sensor could be used tocompensate for variations in upstream suction pressure and preventalarms due to partial occlusions. In this approach, the number ofcommanded pump rotations and rotor speed could be adjusted based on themeasured suction pressure during pumping.

In yet another embodiment, LEDs or other types of lights or lightsources can be located in the top surface of the pump under eachingredient source line. The molded manifold would guide light into thesource tubing line, possibly all the way up to the spike where a visualindication could be provided if a source container or line needsattention. The light or light source would be connected to theelectronic control unit for the compounding device, which would dictatewhen and how to provide light to a particular location, depending onerror codes, programming desires, reminder notices, etc.

While it has been disclosed that a plurality of different sizes andshapes of tubings/lines and containers can be connected to thecompounding device, in yet another alternative configuration of thedisclosed subject matter, the compounding device can be configured foruse with only a single type of container and tubing, such as only macrolines and macro containers, or only micro lines and micro containers. Inthis manner, the compounding device can be an effective replacement forcurrent compounding systems and applications that include only singletypes of containers and lines.

The number of channels can also vary and remain within the scope of thepresently disclosed subject matter. For example, three, four or moredifferent sized channels could be incorporated into the manifold.Similarly, more than one same shaped and sized channel could be includedin the manifold 20.

The strain relief clip 33 is disclosed as being pre-assembled to thelines 2011 and 2021. However, it should be understood that the strainrelief clip 33 or similar structure could be attached during use orinstallation of the manifold. Moreover, the strain relief clip 33 couldbe attached only when its function is needed for a particularapplication. Similarly, the strain relief clip 33 can be configured invarious different shapes and sizes and attached at different locationson the line or tubing. The strain relief clip 33 could also beconfigured as a two piece structure that can be attached at differentlocations on a respective one of the lines. It is also contemplated thatthe strain relief clip 33 can be integrated into the bubble occlusionsensor or vice versa. In addition, the strain relief clip 33 can beconfigured as a dampening material, adhesive or putty that can belocated at a portion of the line(s) and attached to the housing todampen movement of the lines where strain would otherwise be present.

The pump cover door could be mechanically interlocked with a specificposition of platen locks (for example, a user can be prevented fromclosing the door if both platens are not locked into place). A lip canbe provided on a lower portion of the platen to ensure that the userdoes not mislead a pumping segment of the tubing line to a position thatis too low and that would possibly be captured between the platen andthe base of the rotor (instead of being correctly placed on the roller).

The many variations and alternate structures described herein arecontemplated for use in all various combinations and permutations witheach other, and without certain features or components (for example, thefiller can be provided without vanes 202, and the micro channel can beprovided without flex ports 20 bf, etc.)

While the subject matter has been described in detail with reference toexemplary embodiments thereof, it will be apparent to one skilled in theart that various changes can be made, and equivalents employed, withoutdeparting from the scope of the invention. All related art referencesdiscussed in the above Description of the Related Art section are herebyincorporated by reference in their entirety.

What is claimed is:
 1. A method for using a transfer set with acompounding device, comprising: providing the transfer set that includesa housing with at least one primary intake port and at least onesecondary intake port, a first flexible output line extending from thehousing, and a second flexible output line extending from the housing;providing the compounding device that includes a housing, a first pump,and a second pump; connecting the housing of the transfer set to thehousing of the compounding device; leading the first flexible outputline onto the first pump to attach the first flexible output line to thefirst pump; and leading the second flexible output line onto the secondpump to attach the second flexible output line to the second pump. 2.The method of claim 1, further comprising: providing at least one firstflexible input line, and a plurality of second flexible input lines onthe housing; connecting the first flexible input line to a first sourcecontainer; and connecting at least one of the second flexible inputlines to a second source container.
 3. The method of claim 2, wherein across-sectional diameter taken normal to a flow path of the firstflexible input line is different in size as compared to across-sectional diameter taken normal to a flow path of the at least oneof the second flexible input lines.
 4. The method of claim 1, furthercomprising: causing a first fluid to flow through the housing of thetransfer set along a first channel; and causing a second fluid and thirdfluid different from the second fluid to flow through the housing of thetransfer set along a second channel that is different from and separatedfrom the first channel such that the first fluid does not mix with thesecond fluid and third fluid while in the housing, and such that thesecond fluid and third fluid mix within the housing.
 5. The method ofclaim 1, further comprising: providing the housing with at least oneprimary valve that includes a wall; causing fluid to turn greater than90 degrees along a fluid pathway after entering a valve inlet of the atleast one primary valve and prior to exiting a side outlet of the atleast one primary valve.
 6. The method of claim 1, further comprising:placing the housing of the transfer set onto the compounding device toengage at least one attachment structure of the transfer set with amating attachment structure on the compounding device.
 7. The method ofclaim 1, further comprising: providing at least one primary valve in thecompounding device including a primary valve mating structure; matingthe primary valve mating structure with a primary actuator memberlocated on the compounding device when attaching the transfer sethousing to the compounding device.
 8. The method of claim 1, furthercomprising: confirming through the use of a sensor that the housing isin a correct and operational position with respect to the compoundingdevice.
 9. The method of claim 1, further comprising: providing a strainrelief connected to both of the at least one primary flexible outputline and the at least one secondary flexible output line.
 10. The methodof claim 1, further comprising: providing a union junction connected toboth the at least one primary flexible output line and the at least onesecondary flexible output line; mixing fluid from a fluid path definedby the at least one primary flexible output line with fluid from a fluidpath defined by the at least one secondary flexible output line at theunion junction.
 11. The method of claim 1, further comprising: providinga branch junction connected to the at least one secondary flexible inputline; providing a flex line connected to the branch junction and influid communication with the first channel causing a first portion offluid located in the at least one secondary flexible input line upstreamof the branch junction to enter the first channel; and causing a secondportion of fluid located in the at least one secondary flexible inputline upstream of the branch junction to enter the second channel.
 12. Amethod for using a transfer set with a compounding device, comprising:providing the transfer set that includes a housing having a top surface,a bottom surface, and a side surface extending from the top surface tothe bottom surface, the bottom surface configured for attachment to thecompounding device, the top surface of the housing including at leastone primary intake port and at least one secondary intake port, the sidesurface of the housing including a first flexible output line and asecond flexible output line extending from the side surface of thehousing; connecting the bottom surface of the housing to the compoundingdevice; extending the first flexible output line in a directionsubstantially orthogonal to a direction normal to the top surface of thehousing of the transfer set to a first pump; and extending the secondflexible output line in a direction substantially orthogonal to thedirection normal to the top surface of the housing of the transfer setto a second pump.
 13. The method of claim 12, further comprising:providing at least one first flexible input line connected to the atleast one primary intake port, and a second flexible input lineconnected to the at least one secondary intake port; connecting thefirst flexible input line to a first source container; and connectingthe second flexible input line to a second source container differentfrom the first source container.
 14. The method of claim 13, wherein across-sectional diameter taken normal to a flow path of the firstflexible input line is different in size as compared to across-sectional diameter taken normal to a flow path of the at least oneof the second flexible input line.
 15. The method of claim 12, furthercomprising: causing a first fluid to flow through the housing of thetransfer set along a first channel; and causing a second fluid and thirdfluid different from the second fluid to flow through the housing of thetransfer set along a second channel that is different from and separatedfrom the first channel such that the first fluid does not mix with thesecond fluid and third fluid while in the housing, and such that thesecond fluid and third fluid mix within the housing.
 16. The method ofclaim 12, further comprising: providing the housing with at least oneprimary valve that includes a wall; causing fluid to turn greater than90 degrees along a fluid pathway after entering a valve inlet of the atleast one primary valve and prior to exiting a side outlet of the atleast one primary valve.
 17. The method of claim 12, further comprising:pushing the housing of the transfer set down onto the compounding deviceto engage at least one attachment structure of the transfer set with amating attachment structure on the compounding device.
 18. A method forusing a transfer set with a compounding device, comprising: providingthe transfer set that includes a housing with at least one primaryintake port and at least one secondary intake port, a first flexibleoutput line extending from the housing, and a second flexible outputline extending from the housing; providing the compounding deviceincluding a housing with a top surface; connecting the housing of thetransfer set to the top surface of the housing of the compoundingdevice; leading the first flexible output line onto at least one firststructure located on the top surface of the housing of the compoundingdevice; and leading the second flexible output line onto at least onesecond structure located on the top surface of the housing of thecompounding device.
 19. The method of claim 18, wherein the at least onefirst structure is at least one of a first pump, a bridge, a unionjunction, and a strain relief, the at least one second structure is atleast one of a second pump, the bridge, the union junction, and thestrain relief, the top surface of the housing of the compounding deviceis substantially planar, and leading the first flexible output lineincludes leading in a direction substantially parallel with the topsurface of the housing of the compounding device.
 20. The method ofclaim 18, further comprising: rotating a first/micro platen lockclockwise to lock a first platen at a closed position relative to afirst rotor of the first structure, the first structure being a firstpump; and rotating a second/micro platen lock counter-clockwise to locka second platen at a closed position relative to a second rotor of thesecond structure, the second structure being a second pump.